At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 205 enrolled
Drug / intervention
Etanercept +1 moredrug
Likely dose
Etanercept 0.8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Placebo Controlled Study of the Effects of Etanercept in Children Presenting With Kawasaki Disease
In Brief
A Phase 2 clinical trial evaluating Etanercept and Placebo for Mucocutaneous Lymph Node Syndrome and Kawasaki Disease. Completed, enrolled 205 participants across 8 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
CollaboratorsAmgen
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartMar 2009
Primary CompletionJan 2018
Study CompletionAug 2018
TodayJul 2026
First PostedFeb 11, 2009
Enrollment StartMar 1, 2009
Primary CompletionJan 1, 2018
Study CompletionAug 30, 2018
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 17.4 years ago
Interventions
Etanerceptdrug
etanercept 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.
Placebodrug
Placebo 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.